Skin antiseptic applicator and methods of making and using the same

ABSTRACT

The invention relates to applicators for applying a solution or other composition (e.g., an antiseptic composition) to skin of a patient. The applicator may include a container body having a proximal end, a distal end, and a frangible member disposed at the distal end of the body. The applicator includes a first position where the container body and frangible member are a unitary piece (e.g., blow molded as a single piece), and a second position when the frangible member is rotated relative to the body to irreversibly break a weak point therebetween, releasing the composition in the hollow body through an opening. A porous applicator head may be positioned adjacent the distal end of the body and frangible member, so that the composition flows out the body, through the opening, and onto the head. The applicator may be formed in a blow-fill-seal process for improved sterility and ease of manufacture.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/289,383, filed May 28, 2014, which is a continuation of U.S.patent application Ser. No. 14/261,360, filed Apr. 24, 2014. Thisapplication claims the benefit of U.S. Provisional Patent ApplicationSer. No. 61/836,052, filed Jun. 17, 2013. The disclosures of each priorapplication are incorporated by reference in their entirety.

BACKGROUND OF THE INVENTION 1. The Field of the Invention

The present invention is directed to skin antiseptic compositionapplicators, particularly to skin antiseptic composition applicatorsthat include one or more antimicrobial (e.g., antiseptic) materials in asingle use applicator. Typically such skin antiseptic applicators areused in preparation for surgery to decolonize the skin prior to surgeryand provide some protection to the patient's skin after surgery toprevent infection and aid in the healing process.

2. Description of Related Art

Antiseptic preparation of patient's skin for surgery conventionallyincludes a two to ten minute scrubbing of the affected area with anantiseptic soap solution followed by the application of a water-solubleantiseptic composition.

These compositions are generally applied with saturated sponges that areattached to a blade or held with forceps. These sponges are oftensaturated by soaking them in an open pan of antiseptic composition.Sometimes, sponges with attached handles are provided in a plastic oraluminum foil laminate pouch containing enough liquid to saturate thesponge. In some products the sponges are supplied dry in a sterile kitwith the antiseptic composition provided in relatively thin walled 4 oz.plastic bottles.

While inexpensive, these techniques are messy and offer little controlover inadvertent dripping of the composition into areas where it isundesired. Since many of the available compositions contain activeingredients such as alcohol, iodine or chlorhexidine gluconate, drippingor pooling of such compositions at unintended locations can beirritating when left in contact with the skin. As such, good controlover the application has long been desirable, although not alwaysprovided.

Skin antiseptic applicator devices have been developed in an attempt toprevent composition dripping associated with the above techniques, andto reduce the time required for application of the antisepticcomposition. In particular, the ChloraPrep® products commerciallyavailable from CareFusion and the DuraPrep® products commerciallyavailable from 3M have enjoyed commercial success by providingsubstantially drip-free, convenient application of antisepticcompositions compared to the conventional techniques described above.

One of the challenges associated with using such skin antisepticcompositions is the need to sterilize the exterior of the applicatorwhile minimizing potential byproducts that may be produced when thecomposition is exposed to sterilization compounds such as ethylene oxidegas. Reactive sterilants such as ethylene oxide may react with theactive antimicrobial agent or with other components in the skinantiseptic composition, altering the potency or producing potentiallytoxic compounds.

To address this problem, various solutions have been proposed. Forexample, the ChloraPrep® applicator, provided by CareFusion, has theactive skin antiseptic composition, containing chlorhexidine gluconate(CHIG), stored in a breakable glass ampule inside the applicator device.In the ChloraPrep® applicator, the sealed glass ampule protects the CHGcomposition during the sterilization process from ethylene oxidepenetration which could otherwise compromise the efficacy of theantiseptic composition. CareFusion has a number of patents and patentapplications including: U.S. Pat. Nos. 5,772,346 and 5,752,363 and U.S.Application Publication No. 2012/003029. Each of these teach the use ofa sealed glass ampule containing CHG inside a skin antisepticapplicator.

An alternative solution to this problem is to construct the applicatorcontainer walls with layers of materials that are functionallyimpermeable to ethylene oxide gas. For example, U.S. ApplicationPublication No. 2001/0054562 to Petterson, teaches a sealed medicaldevice with a barrier layer to prevent ethylene oxide penetration byhaving the applicator walls made of a laminate material having an innerlayer of polyolefin, an intermediate layer of silicon oxide and anexterior layer of polyethylene. Similarly, U.S. Pat. No. 8,105,306,assigned to 3M, teaches a skin antiseptic applicator with a containerhaving a first interior layer of a polyolefin material which isimpermeable to the liquid and vapor phases, and a barrier layer ofpolyester adhered to the interior layer which is impermeable to gaseousethylene oxide. In the 3M applicator, both layers are free of siliconoxide. Another example is U.S. Application Publication No. 2012/184929,assigned to 3M, which teaches a skin antiseptic applicator with acontainer having a first interior layer which is permeable to the liquidand vapor phases, an adhesive layer for adhering the barrier layer tothe interior layer, and a barrier layer which is impermeable to gaseousethylene oxide.

One recurring problem with such existing skin antiseptic applicators isthat the solutions provided to minimize ethylene oxide penetration alsoadd additional cost and complexity to the applicator devices. From amanufacturing perspective, it would be preferable to provide anapplicator having a container wall with only one layer (e.g., ahomogenous layer) of material, rather than requiring multiple differentlayers. In addition, to reduce costs and simplify manufacturing of thesedevices, it would be an improvement to provide an applicator with asingle compartment containing the skin antiseptic composition, insteadof multiple initially separated compartments, or a sealed glass ampuleinside of the applicator container.

One of the challenges associated with these skin antiseptic applicatorsis that the CHG or similar antiseptic compositions are often not stablewith dye components. It is desirable to have a dye of a skin contrastingcolor along with the skin antiseptic composition, because then thepractitioner applying the skin antiseptic composition to the patient andother healthcare providers who subsequently interact with the patientcan more readily see where the composition has been applied on the skin.One solution is to provide the CHG composition in a separate compartmentfrom a dye composition. For example, the ChloraPrep® applicators havethe CHG composition in a glass ampule and the dye composition isprovided in the foam applicator head. In the ChloraPrep® applicator theCHG composition flows through the dye and mixes with the dye in theapplicator head. Another example of a two chamber applicator isdescribed in U.S. Pat. No. 8,348,537, assigned to Covidien, whichteaches an applicator with side-by-side, initially separate chambers forhousing an antiseptic composition in one chamber and a dye in the otherchamber. In the Covidien applicator, the dye and the antisepticcomposition mix just prior to reaching the applicator head.

One problem with such existing skin antiseptic applicators containingmultiple compartments for housing the dye separate from the antisepticcomposition is that a multi-chamber applicator increases costs andcomplexity in the manufacturing process. From a manufacturingperspective, it would be preferable to provide an applicator needingonly one compartment. In addition, it is preferable from a useperspective to have the dye and the antiseptic composition as onecomposition, as then the practitioner does not have to worry aboutmixing the two compositions together prior to application, and iteliminates the possibility that the antiseptic composition might bedelivered to the patient's skin without dye or without sufficient dye toreadily indicate to the practitioner where the product has been applied.

In view of the current state of the art, there is a continuing need forimproved applicator products.

BRIEF SUMMARY

In an embodiment, the present invention is directed to an applicator forapplying a composition (e.g., an antiseptic composition, personal carecomposition, etc.), comprising a container body having a proximal endand a distal end wherein the container body has a frangible memberpositioned at the distal end of the container body wherein theapplicator has a first position where the container body and frangiblemember are a unitary structure, and a second position where thefrangible member is rotated relative to the rest of the container bodyabout a longitudinal axis to break a weak point and release thecomposition in the container body, allowing the composition to flow outof the container body through at least one opening. In one embodiment ofthe invention, a user may start with the applicator in a first positionwhere the container body and the frangible member are a unitarystructure, move to a second position to break the frangible member byrotating the frangible member relative to the container body, and thenimmediately move to a third position where the alignment between thecontainer body and the frangible member is similar as it was in thefirst position except now the frangible member is bent and/or brokenaway from the container body: The applicator may be used either in thesecond position or in the third position to apply the antimicrobialcomposition to the patient's skin. The applicator also includes anapplicator head formed of at least one porous material, positionedadjacent the distal end of the container body and the frangible member,wherein the composition flows out of the container body through theopening and onto the applicator head.

Another embodiment is directed to an applicator for applying acomposition comprising a container body having one or more walls formedof a single layer of material that is substantially impervious toethylene oxide, wherein the container body has a proximal end and adistal end, wherein the container body has a frangible member positionedat the distal end of the container body. The composition applicator hasa first position where the container body and frangible member are aunitary structure that forms a sealed applicator, and a second position,when the frangible member breaks away from the rest of the containerbody at a weak point therebetween, creating at least one opening toallow the composition to flow out of the container body. In the secondposition the frangible member is rotated relative to the rest of thecontainer body about a longitudinal axis. The applicator furtherincludes an applicator head formed of at least one porous material,positioned adjacent to the distal end of the container body and thefrangible member. The composition flows out of the container body ontothe applicator head.

Another embodiment is directed to an applicator for applying acomposition, the applicator consisting essentially of a container bodyhaving a proximal end and a distal end, wherein the container body has afrangible member positioned at the distal end of the container body. Theapplicator has a first position where the container body and frangiblemember are a unitary structure that forms a sealed applicator, and asecond position, when the frangible member breaks away from the rest ofthe container body at a weak point therebetween, creating at least oneopening to allow the composition to flow out of the container body. Theapplicator further includes an applicator head (e.g., formed of a porousmaterial), positioned adjacent to the distal end of the container bodyand the frangible member. The composition flows out of the containerbody onto the applicator head. An antiseptic composition is initiallystored in the container body, and includes a dye or colorant and anactive selected from the group consisting of an antimicrobial agent, anantiviral agent, an antiseptic agent, and any combinations thereof.Optionally, the container body may include a barrier layer thereon tominimize ethylene oxide penetration. Alternatively, the container bodymay have a barrier material on a portion of the exterior of thecontainer body. The barrier material may be a single material or acombination of materials and may have a continuous or a discontinuousform covering less than 100% of the exterior surface area of thecontainer body. Suitable examples of barrier materials may include, butare not limited to: a printed pattern coating (stripes, dots, companylogos, etc.), a shrink label, an adhesive label or sticker, a sleeve, aband, or other suitable alternatives.

Another embodiment is directed to a composition applicator comprising acontainer body having a proximal end and a distal end wherein thecontainer body has a frangible member positioned at the distal end ofthe container body wherein the applicator has a first position where thecontainer body and frangible member are a unitary structure, and asecond position where the frangible member is broken away from thecontainer body at a weak point therebetween and the frangible member isrotated out of alignment with the container body. The container body mayinclude a sterile, aseptic composition provided therein, where theaseptic composition flows out of the container body through one or moreopenings created when the applicator is in the second position. Theapplicator also includes an applicator head formed of at least oneporous material, positioned adjacent the distal end of the containerbody, wherein the composition flows out of the container body throughthe opening and onto the applicator head.

Another embodiment is directed to a composition applicator comprising acontainer body having one or more walls formed of a single layer ofmaterial that is substantially impervious to ethylene oxide, wherein thecontainer body has a proximal end and a distal end, wherein thecontainer body has a frangible member positioned at the distal end ofthe container body. The applicator has a first position where thecontainer body and frangible member are a unitary structure that forms asealed applicator, and a second position, when the frangible memberbreaks away from the rest of the container body at a weak pointtherebetween, creating at least one opening to allow the composition toflow out of the container body. In one embodiment, at least 60% of thesurface area of the container body consists of a single layer ofmaterial, and the container body exhibits permeability to gaseousethylene oxide of 20 mg/hr/cm², or less. The applicator further includesan applicator head formed of at least one porous material, positionedadjacent to the distal end of the container body and the frangiblemember. During use, once the frangible member is broken away, thecomposition flows out of the container body onto the applicator head.

Another embodiment is directed to a composition applicator comprising acontainer body having a proximal end and a distal end, wherein thecontainer body has a frangible member positioned at the distal end ofthe container body. The composition applicator has a first positionwhere the container body and frangible member are a unitary structureformed of a single layer of material that is substantially translucent,and a second position, when the frangible member breaks away from therest of the container body at a weak point therebetween, creating atleast one opening to allow the composition to flow out of the containerbody. In some embodiments of the invention, the applicator may have athird position where the alignment between the container body and thefrangible member is similar as it was in the first position except nowthe frangible member is bent and/or broken away from the container body.The applicator further includes an applicator head formed of at leastone porous material, positioned adjacent to the distal end of thecontainer body and the frangible member. During use, once the frangiblemember is broken away, the composition flows out of the container bodyonto the applicator head. An aseptic composition is provided within thecontainer body, the aseptic composition comprising: (i) an activeselected from the group consisting of an antimicrobial agent, anantiviral agent, an antiseptic, and any combination thereof; (ii) analcohol; and (iii) a dye or colorant. The composition does notnecessarily need to be aseptic. For an antimicrobial applicator, it maybe preferred that the composition is aseptic, but it is not required.Whether the composition is aseptic will depend on the intended use ofthe applicator.

Another embodiment is directed to a method of making an asepticapplicator, the method comprising the steps of extruding a polymericmaterial, placing the extruded material into a blow mold, molding theextruded material by placing a blow pin into the neck of the extrudedmaterial using pressure to form the material into a container bodyshape, filling the container body using the blow pin with an asepticcomposition comprising an antimicrobial agent, an alcohol, and a dye orcolorant, retracting the blow pin to create a frangible member andsealing the filled container body, and attaching a porous applicatorhead to the unitary structure to form the aseptic applicator. Thefrangible member attached to the distal end of the container body andthe container body itself form a sealed, unitary structure.

Another embodiment is directed to a method of making an asepticcomposition applicator, the method comprising the steps of (a) extrudinga polymeric material; (b) placing the extruded material into a blowmold; (c) molding the extruded material by placing a blow pin into theneck of the extruded material using pressure to form the material into acontainer body shape; (d) using the blow pin, filling the container bodywith an aseptic composition comprising an antimicrobial agent, analcohol, and a dye or colorant, (e) retracting the blow pin to create afrangible member attached to the distal end of the container body suchthat the container body and frangible member form a sealed, unitarystructure, and sealing the filled container body using vacuum pressure;(f) attaching a porous applicator head to the unitary structure to formthe aseptic applicator; and (g) sterilizing the aseptic applicator usingethylene oxide gas.

Another embodiment is directed to a method of making an asepticapplicator, the method comprising the steps of (a) extruding a polymericmaterial; (b) placing the extruded material into a blow mold; (c)molding the extruded material by placing a blow pin into the neck of theextruded material using pressure to form the material into a containerbody shape; (d) using the blow pin, filling the container body with anaseptic composition comprising an antimicrobial agent, an alcohol, and adye or colorant, (e) retracting the blow pin to create a frangiblemember attached to the distal end of the container body such that thecontainer body and frangible member form a sealed, unitary structure,and sealing the filled container body using vacuum pressure; (f)attaching a porous applicator head to the unitary structure to form theaseptic applicator; (g) sterilizing the aseptic applicator usingethylene oxide gas; and (h) packaging the sterilized aseptic applicatorinto an external packaging comprising at least one flexible portion.

Further features and advantages of the present invention will becomeapparent to those of ordinary skill in the art in view of the detaileddescription of preferred embodiments below.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of thepresent invention, a more particular description of the invention willbe rendered by reference to specific embodiments thereof which areillustrated in the drawings located in the specification. It isappreciated that these drawings depict only typical embodiments of theinvention and are therefore not to be considered limiting of its scope.The invention will be described and explained with additionalspecificity and detail through the use of the accompanying drawings inwhich:

FIG. 1A is a perspective view showing an exemplary applicator accordingto the present invention;

FIGS. 1B and 1C are side perspective view of the applicator of FIG. 1A,showing before and after activation, respectively;

FIG. 2 is an exploded view of the applicator of FIG. 1A;

FIG. 3 is a perspective view of the applicator of FIG. 1A, in a firstposition, prior to breaking of a weak point between the frangible memberand the container body, shown with the porous applicator head removed tomore clearly illustrate the container body and frangible member;

FIG. 3A is a close up view of the applicator of FIG. 3, showing thefrangible member and distal end of the container body;

FIG. 4A is a cross-sectional view through the distal end of thecontainer body, showing the frangible member in the first positionrelative to the container body;

FIG. 4B is a cross-sectional view similar to that of FIG. 4A, butshowing the frangible member in the second position, such that the weakpoint between the container body and frangible member has been broken,allowing composition in the container body to flow out the body throughan opening and onto the applicator head;

FIG. 5A is a perspective view of another exemplary applicator having analternative configuration;

FIG. 5AA is a close up view of the distal end of the container body andfrangible member of FIG. 5A;

FIG. 5B is a perspective view of the distal end of another exemplaryapplicator having an alternative configuration;

FIG. 6 is a flowchart illustrating an exemplary method according to thepresent invention; and

FIG. 7 shows the exemplary applicator of FIG. 1A in a sealed package.

DETAILED DESCRIPTION I. Definitions

Before describing the present invention in detail, it is to beunderstood that this invention is not limited to particularlyexemplified systems or process parameters that may, of course, vary. Itis also to be understood that the terminology used herein is for thepurpose of describing particular embodiments of the invention only, andis not intended to limit the scope of the invention in any manner.

All publications, patents and patent applications cited herein, whethersupra or infra, are hereby incorporated by reference in their entiretyto the same extent as if each individual publication, patent or patentapplication was specifically and individually indicated to beincorporated by reference.

The term “comprising” which is synonymous with “including,”“containing,” or “characterized by,” is inclusive or open-ended and doesnot exclude additional, unrecited elements or method steps.

The term “consisting essentially of” limits the scope of a claim to thespecified materials or steps “and those that do not materially affectthe basic and novel characteristic(s)” of the claimed invention.

The term “consisting of” as used herein, excludes any element, step, oringredient not specified in the claim.

It must be noted that, as used in this specification and the appendedclaims, the singular forms “a,” “an” and “the” include plural referentsunless the content clearly dictates otherwise. Thus, for example,reference to a “surfactant” includes one, two or more surfactants.

Various aspects of an antiseptic composition applicator may beillustrated by describing components that are coupled, attached, and/orjoined together. As used herein, the terms “coupled”, “attached”, and/or“joined” are used to indicate either a direct connection between twocomponents or, where appropriate, an indirect connection to one anotherthrough intervening or intermediate components. In contrast, when acomponent is referred to as being “directly coupled”, “directlyattached”, and/or “directly joined” to another component, there are nointervening elements present.

Various aspects of an antiseptic applicator may be illustrated withreference to one or more exemplary embodiments. As used herein, the term“exemplary” means “serving as an example, instance, or illustration,”and should not necessarily be construed as preferred or advantageousover other embodiments of an antiseptic applicator disclosed herein.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which the invention pertains. Although a number of methodsand materials similar or equivalent to those described herein can beused in the practice of the present invention, the preferred materialsand methods are described herein.

In the application, effective amounts are generally those amounts listedas the ranges or levels of ingredients in the descriptions, which followhereto. Unless otherwise stated, amounts listed in percentages (“wt%'s”) are in wt % (based on 100 weight % active) of the particularmaterial present in the referenced composition, any remaining percentagetypically being water or an aqueous carrier sufficient to account for100% of the composition, unless otherwise noted. For very low weightpercentages, the term “ppm” corresponding to parts per million on aweight/weight basis may be used, noting that 1.0 wt % corresponds to10,000 ppm.

II. Introduction

The present disclosure is directed to composition applicators andrelated methods of manufacture for providing antiseptic compositionapplicators that provide for prevention of contact between thepractitioner and the skin of the patient, so as to avoid contamination.This may be accomplished by providing a container body to the applicatorincluding a handle that may typically be about 4-6 inches long, with thehandle oriented at an angle (e.g., 10-85 degrees) relative to the headof the applicator, through which head the composition is dispensed. Theapplicators include a frangible member that is initially a unitarystructure with the remainder of the container body, providing a sealedcompartment containing the composition that protects the compositionduring a sterilization process, and prevents the composition fromflowing out of the applicator prematurely. The frangible member may bemoved (e.g., rotated, bent, pulled away from, etc.) relative to theremainder of the container body, irreversibly breaking the seal, andproviding an opening so that the composition can flow out of thecontainer body through the opening, onto the porous applicator head, soas to allow delivery of the composition to the skin of the patient.

III. Exemplary Composition Applicators

The composition applicator may be compact and economically designed. Asshown in FIGS. 1A-3A, a composition applicator 100 may comprise asubstantially hollow container body 102, extending from a proximalgripping end 104 to a distal delivery end 106. A frangible member 108may be positioned at distal end 106 of container body 102. Asmanufactured, container body 102 and frangible member 108 are initiallya unitary structure, sealing a composition within hollow container body102. This unitary configuration is referred to herein as a firstposition of the composition applicator. The composition applicator 100further has a second position where the frangible member 108 is rotatedrelative to the remainder of container body 102 about longitudinal axisA to break a weak point (e.g., a region of narrowed cross-sectionalthickness) 110 between frangible member 108 and the remainder ofcontainer body 102. Upon irreversible breakage, the composition withinhollow container body 102 is free to flow out of body 102, through anopening at break point 110, and onto porous applicator head 112. Head112 may comprise a porous, soft, readily deformable material (e.g.,foam, nonwoven material, fabric, cotton swab, etc.) positioned adjacentdistal end 106 of container body 102 and frangible member 108.

Container body 102 may be of any desired shape (e.g., tubular in shape,cylindrical, triangular or oval cross-section, etc.). The container body102 may include one or more compartments for housing the composition, ora component portion thereof. For example, liquids, gels and/or solidsmay be stored therein. Where multiple compartments are provided, theymay be provided initially separate from one another, so as to allowmixing of the components from the various compartments just prior touse. The container body 102 may be elongate and tubular in shape. In oneembodiment, the transverse cross-sectional shape of container body 102may be circular, rounded, or oval. The Figures, particularly FIGS. 4A-4Bshow an oval cross-sectional shape. The container body 102 may have atransverse cross-section (e.g., as perhaps best seen in FIGS. 4A-4B)with an x-axis and a y-axis of unequal lengths. The end adjacentproximal end 104 is shown as generally flat, although it will beappreciated that in another embodiment the body 102 may have its sidessealed together at the proximal end 104, similar to a tube of toothpasteor antiseptic ointment.

In any case, the container body may be any suitable shape or size thatcan easily be grasped in one hand by a user. In an embodiment, theapplicator may allow a practitioner to move between the first and secondpositions using only a single hand (e.g., by pressing head 112 against asurface, and twisting handle 103, while friction against the surfaceholds head 112 (and thus frangible member 108) stationary. In anembodiment, an external film, griping members or grip design (e.g., anelastomeric material overmolded on the handle portion 103 of containerbody 102) may be provided to aid the user in gripping and handling theapplicator 100.

In an embodiment, the container body 102 may be symmetrical aboutlongitudinal axis A. Along a latitudinal axis or transversecross-sectioning plane, the container body 102 may include differentshaped cross-sections at different points along the longitudinal axis ofthe container body. The container body 102 may include at least aportion thereof that can be seen through (e.g., transparent ortranslucent). Such a container body 102 may allow the practitioner toview the composition stored within hollow container body 102, e.g.,allowing the practitioner to view the level of the composition withinthe applicator, as it is dispensed, and its level drops. In anembodiment, the entire container body may be formed of the same material(e.g., through a blow-fill-seal process). In another embodiment,container body 102 may include a window portion (e.g., an elongateviewing stripe) formed of such a transparent or translucent material. Insuch an embodiment, the remainder of container body 102 may be opaque.For example, it may include an inorganic oxide or colorant compoundedwith the polymeric material from which it is formed, or included as adiscrete layer separate from the polymeric material. FIG. 5A shows suchan otherwise opaque container body with a viewing window or elongatestripe.

Container body 102 may include one or more walls formed of a singlelayer of material, as may be provided through a blow-fill-seal process.The single layer of material may be substantially impervious to ethyleneoxide (e.g., as used to sterilize the applicator). For example, thewall(s) of container body 102 may exhibit a permeability to gaseousethylene oxide of 20 mg/hr/cm² or less. In an embodiment, thepermeability may be such so that the composition contained within body102 includes less than 250 ppm, less than 100 ppm, or less than 25 ppmof residual ethylene oxide (e.g., after sterilization).

Container body 102 may include a neck 114 at its distal end 106,adjacent frangible member 108. Neck 114 may include reduced dimensionsrelative to the handle portion 103 of body 102, and may include adifferent cross-sectional shape as compared to handle portion 103 ofbody 102. For example, while handle portion 103 is shown as being ovalin cross-section, neck 114 may be generally circular. Neck 114 mayinclude ramped protrusions 116 formed thereon which extend radiallyoutward, so as to define a plurality of recesses 118 between adjacentprotrusions 116 of neck 114. Wings 120 provided on frangible member 108may be received within recesses 118, between protrusions 116, aiding inmaintaining the applicator in the first or second position. For example,such a configuration may prevent inadvertent twisting and breakage offrangible member 108 relative to the remainder of container body 102prematurely. In addition, once breakage of frangible member 108 hasoccurred, engagement provided between wings 120 and the appropriatecorresponding recesses 118 defined between protrusions 116 may aid inmaintaining the applicator in the second position (e.g., with frangiblemember 108 rotated relative to the remainder of container body 102.

FIG. 1A shows applicator 100 with handle portion 103 of container body102 and frangible member 108 in the first position, prior to fracture ofa weak point 110 sealing the composition within body 102. Like FIG. 1A,FIG. 1B shows applicator 100 prior to activation. FIG. 1C showsapplicator 100 with handle portion 103 and frangible member 108 in thesecond position, after fracture, allowing the composition within body102 to flow out onto porous head 112. FIGS. 4A-4B (also showing viewsbefore and after fracture, respectively) perhaps best illustrate thegeometry of the protrusions 116, corresponding recesses 118, and wings120 of frangible member 108 that are received therein. As seen in FIGS.1A-1B, in the first position, the long axis of the oval transversecross-section of body 102 through handle portion 103 may be generally“horizontal”, relative to the flat, horizontal surface provided by abottom of foam head 112. As seen in FIG. 1C, the long axis of the ovaltransverse cross-section of body 102 through handle portion 103 may begenerally “vertical” relative to the flat, generally horizontal surfaceat the bottom of foam head 112 (e.g., which would contact the patient'sskin during use).

FIG. 4A shows the frangible member 108 and remainder of container body102 in the first position, that of FIG. 3. FIG. 4B shows frangiblemember 108 having been rotated relative to the remainder of body 102,about longitudinal axis A, causing breakage of weak point 110, so as toallow initiation of flow of the composition within hollow body 102. Asseen in FIG. 4A, wings 120 initially (in the first position) residewithin recess 118 ₁, defined between recess 116 c and 116 a. Referringto FIG. 4A, frangible member 108 may be rotated in a clockwise directionabout neck 114 of container body 102, over first protrusion 116 a, andinto the recess defined between protrusions 116 a and 116 b. Furtherclockwise rotation of wing 120 (and frangible member 120) over secondprotrusion 116 b, into recess 118 ₂, is sufficient to irreversiblyfracture weak point 110, permitting flow of the composition out ofinitially sealed container 102. FIG. 4B shows the second position, oncefrangible member 108 and wings 120 have been rotated, so that wings 120reside within recesses 118 ₂.

Protrusions 116 (e.g., 116 a-116 c) may be progressively larger than oneanother, so that protrusion 116 c includes a lateral extension from neck114 that is greater than the extension of protrusion 116 b, and theextension of protrusion 116 b is greater than that of protrusion 116 a(i.e., extension of 116 c>116 b>116 a). As is apparent from FIG. 4A, twoof each protrusion may be provided, each set of protrusions 116 a-116 ccorresponding to one of wings 120, as frangible member is rotated aboutneck 114 to break weak point 110. In addition to the progressivelyincreasing lateral extension of the protrusions 116, the protrusions 116may provide a ramped leading edge angle to facilitate wing 120 ridingover protrusions 116 a and 116 b, but stopping against protrusion 116 c.

For example, the leading edge angle of protrusion 116 a over which wing120 rides may be greater than 90°, so as to provide some initialthreshold resistance against rotation over protrusion 116 a, but stillallow such rotation, when desired. In an embodiment, the leading edgeangle of protrusion 116 a may be from about 135° to about 175°, fromabout 140° to about 170°, or from about 145° to about 165° (i.e.,presenting an incline to wing 120 of about 5° to about 45°, 10° to about40°, or from about 15° to about 35°). The leading edge angle ofprotrusion 116 b may be within similar ranges. The leading edge angleprovided by protrusion 116 c may be much steeper, so as to act as a stopagainst further rotation of frangible member 108. For example, theleading edge angle provided by protrusion 116 c may be from about 70° toabout 105°, from about 75° to about 105°, or about 80° to about 105°(i.e., presenting an incline to wing 120 of about 75° to about 110°,about 75° to about 105°, or about 75° to about 100°).

Lateral extension of wing 116 c may be about 50% to about 100% more thanprotrusion 116 b, and about 200% to about 300% more than protrusion 116a, as the lateral extension of the protrusions are progressively larger,“proud”, or more prominent than one another. As a result of theincreased lateral extension and the increasingly steep incline presentedto wing 120 by protrusions 116, a minimum threshold force is needed toinitiate breakage of frangible member 108, while also providing a stopto prevent further rotation of wing 120, once the second position wherefrangible member 108 is broken, has been assumed. While theconfiguration shown includes 3 different sets of protrusions for eachwing, it will be appreciated that fewer or more may be provided. Forexample, a configuration may only include first and third protrusions116 a and 116 c, respectively, the protrusion 116 a serving to require athreshold amount of force to ride thereover so as to get out of thefirst position, and protrusion 116 c serving as a stop to preventrotation past the second position.

Distal to neck 114, an undercut portion 122 in the distal end 106 ofcontainer body 102 may be provided. In the illustrated embodiment,undercut portion 122 is positioned between neck 114 and the openingformed at weak point 110 upon breakage of weak point 110. Frangiblemember 108 may further be provided with one or more protrusions 124,which correspond to undercut portion 122 and extend inwardly (e.g.,towards axis A) so as to be received within the undercut laterallyadjacent to portion 122. Reception of protrusions 124 within theundercut adjacent portion 122 prevents up and down (proximal-distal)movement of frangible member 108 relative to the remainder of containerbody 102, even after assuming the second position, where frangiblemember has been broken relative to the remainder of body 102, so thatmember 108 and the remainder of body 102 are no longer a unitarystructure. Of course, porous head 112 may also aid in retainingfrangible member 108 in place, when in the second position.

As seen in FIGS. 4A and 4B, and described above in conjunction withFIGS. 1A-1C, in the first position, where container body includes anoval transverse cross-section through the handle portion 103, the ovalmay be oriented so that the longer axis of the oval is generallyhorizontal in the first position. Upon rotation and breakage of the weakpoint of the frangible member 108, the handle portion 103 has beenrotated relative to the head 112 so that the longer axis of the oval isnow generally vertical in the second position. For example, as seen, therotation to move between the first and second positions may be about 800to about 120°, or about 90° to about 1100. By providing the handleportion 103 with an oval cross-section, and providing the secondposition to correspond to a configuration where the head 112 remains asin the first position, but the handle portion 103 rotates so that thelong axis of the oval is now generally vertical, the practitioner canreadily determine which position the applicator is in. In addition,providing the second position with the oval's long axis in the generallyvertical orientation facilitates improved gripping of the applicator inthe hand of the practitioner, as compared to alternative orientations(e.g., with the long axis horizontal).

Head 112 may cover all or a portion of wings 120, protrusions 116, andrecesses 118. For example, as shown in FIGS. 1A-1C, head 112 may extendproximally to a sufficient length to cover a portion of wings 120,protrusions 116, and recesses 118, while still allowing the mostproximal portion of neck 114, protrusions 116, recesses 118, and wings120 to be seen during use. Being able to see such structures may aid thepractitioner in knowing how far frangible member 108 has been rotatedrelative to the remainder of body 102, and visually ascertaining whetherthe second position in which weak point 110 has been broken is achieved.Of course, upon fracture of weak point 110, a tactile and/or audibleindicator (e.g., a “crack” both felt and/or heard) may also be provided,as the weak point 110 breaks.

The coverage of frangible member 108 by head 112 may also serve toprovide good engagement between head 112 and frangible member 108, so asto ensure that head 112 and frangible member 108 rotate together duringmovement from the first position to the second position. For example, inan embodiment, head 112 may cover at least 50% of the surface area ofthe frangible member. As shown, frangible member 108 may include agenerally flat, rectangular distal flange portion 126, providingengagement with head 112. Head 112 may include a correspondingly shapedrecess 111 into which flange 126 and other structures of the coveredportion of frangible member 108 are received. Frangible member 108 mayinclude proximally extending wings 120 adjacent neck 114, describedabove, and inwardly extending protrusions 124, each of which may bereceived, at least in part by covering applicator head 112.

In order to provide undercut portion 122 with undercuts at both proximaland distal ends, an enlarged cylindrical stop 128 may be provided distalto undercut portion 122. The distal top of stop 128 may include aconical taper towards weak point 110, and a sealing cap 130, alsoenlarged in transverse cross-section relative to weak point 110 may beprovided atop stop 128, so that weak point 110 is defined between top128 and sealing cap 130. In an embodiment, frangible member 108 may beattached to the remainder of container body 102 only at its distal end,e.g., flange 126 attached to sealing cap 130. The wings 120 extendingproximally from flange 126 may not be connected directly to the adjacentstructures of the remainder of container body 102 (e.g., wings 120 mayinclude a small space or gap 121 between stop 128 and wings 120. Thisspace or gap 121 may continue proximally, so that wings are near, butnot attached to undercut portion 122, and neck 114. The close upillustration of FIG. 3A may best illustrate this gap 121. While wings120 may ride over protrusions 116, they may not be attached thereto. Asshown, the proximal end of wings 120 may extend to a neck 115 justproximal to neck 114, below or proximal to protrusions 116, extendinginwardly into this undercut neck 115 defined between the oval bottleshape portion of container 102 and neck 114.

The large surface area and planar shape provided by flange 126 andelongate, proximally extending wings 120 provides a large area forengagement with a corresponding inside recess 111 of applicator head112, to ensure that head and frangible member remain together, astwisting from the first to the second position occurs, preventingfrangible member 108 from “slipping” inside head 112 as twisting andbreakage of the weak point is achieved.

Applicator head 112 may be attached to body 102 by any suitable means,including, but not limited to a snap fit, adhesive, friction fit, tabsor undercuts in the plastic body to hold the porous head 112 in place,hook and loop, screw on, etc. Porous applicator head 112 may be formedof a wide variety of materials, including but not limited to foam,sponge, non-woven fibrous substrates, woven fibrous substrates, etc. Theporous material may be selected to provide a desired soak rate, or maybe provided with structure features (e.g., slits, apertures, channels,differing foam density within portions of head 112, foam cellcharacteristics, etc.) to direct and control flow of the compositionthrough applicator head 112.

Container body 102 may contain an aseptic composition therein. Thecomposition may comprise a dye or colorant to provide a color (e.g.,red, purple, green, etc.) to the composition so as to contrast againstthe skin to which the composition is to be applied. The composition mayalso include an active selected from the group consisting of anantimicrobial agent, an antiviral agent, an antiseptic agent, and anycombinations thereof. By way of example, the active included in thecomposition is not particularly limited, and may be chlorhexidine, or achlorhexidine salt, such as chlorhexidine gluconate. Other actives(e.g., povidone iodine (PVP-I), iodine, or other iodine complexes mayalso be used, as well as any other antimicrobial agents. An alcohol mayalso be included (e.g., methanol, ethanol, isopropyl alcohol, butylalcohol, combinations thereof, etc.). The composition may be a liquid.In some embodiments, liquid components may mix with solid, gel, or otherliquid components to result in a flowable liquid composition.

The composition contained within the body 102 may be aseptic, meaning itis generally sterile, so as to be free from disease causing contaminants(e.g., bacteria, viruses, fungi, parasites, etc.). The aseptic conditionmay be achieved through manufacture within a controlled environment,where contaminants are controlled, as well as through sterilization ofthe applicator once manufactured (e.g., through exposure to ethyleneoxide gas). As will be apparent from the above, the composition may alsobe an antiseptic composition, where an antiseptic agent is includedtherein, so as to allow its application to skin so as to kill microbes,reducing the possibility of infection. Thus, the composition may beaseptic, and also antiseptic.

A barrier material acting as a barrier to ethylene oxide may optionallybe provided on container body 102, so as to further limit ethylene oxidepenetration through body 102, if desired. In an embodiment, no suchseparate barrier layer is provided, but rather the body 102 comprises asingle layer of material. In such an embodiment, a barrier material maybe incorporated into the single layer of material (e.g., compounded intothe polymeric material from which the body 102 is formed). An example ofsuch a barrier material is an inorganic oxide, such as a metal oxide. Inanother embodiment, a separate distinct layer of such an inorganic oxidebarrier material may be provided.

The container body 102 and frangible member 108 may be formed from thesame unitary piece of material (i.e., simple, one-piece design). In anembodiment, it is desirable to minimize the number of separate parts(e.g., a unitary container body/frangible member and an applicatorhead). Examples of suitable polymeric materials from which the containerbody 102 and frangible member 108 may be formed include, but are notlimited to polyolefins, polypropylene, polyethylene (e.g., high densitypolyethylene, low density polyethylene), ethylene/propylene copolymers,ethylene/butylene copolymers, vinyl and vinyl polymers, acrylicpolymers, polyesters (e.g., polyethylene terephthalate (PET),polybutylene terephthalate), polyvinyl alcohol, polyamides,polyvinylchloride, polyvinylidene chloride, ethylene vinyl alcohol, andany combinations or mixtures thereof. Fluorinated polymers, or layersmay be employed, such as chlorotrifluoroethylene,polytetrafluoroethylene (PTFE), polyvinylidene fluoride, copolymers ofperfluorinated monomers with partially fluorinated monomers such ascopolymers of tetrafluoroethylene/hexafluoropropylene/vinylidene (e.g.,THV fluorothermoplastic from Dyneon Co.), and combinations thereof. Inan embodiment, a blend of HDPE and polyamide may be employed to form asingle layer container body.

Inorganic oxides (e.g., metal oxides) may be incorporated into anysuitable polymeric material, as a barrier material, to decreasepermeability of the resulting material to ethylene oxide penetration. Inanother embodiment, such a barrier material may be present as aseparate, distinct layer (on the outside or inside of a polymeric walllayer, or sandwiched between various layers (e.g., between two polymericwall layers). In another embodiment, the walls of the container body 102may be substantially free of metal oxides (e.g., not intentionallyadded). Exemplary inorganic oxides include, but are not limited tosilicon oxide, aluminum oxide, zinc oxide, magnesium oxide, andcombinations thereof.

The polymeric material from which container body 102 is formed may beflexible, so as to deform under pressure (e.g., as applied by the handof a practitioner squeezing handle 103). By blow molding container 102of a polymeric material having such flexibility characteristics, and anappropriate wall thickness, such flexibility, deformability, and theability to dispense the composition by squeezing handle portion 103 ofbody 102 may advantageously be provided. The walls of container 102 mayexhibit sufficient strength so as to minimize and/or prevent undesirablestress-fracturing of the container (e.g., handle portion 103) due torepeated squeezing and releasing of the bottle shaped handle portion103. A blow-fill-seal procedure may provide such benefits, as comparedto, for example, thermoforming.

FIGS. 5A and 5B illustrate additional alternative embodiments ofexemplary applicators. FIG. 5A shows an applicator 200 similar toapplicator 100, but with a differently configured frangible member 208and surrounding distal portions of container body 202. In applicator200, wings 220, including protrusions 224 may be attached to neck 214and undercut portion 222, respectively, with a gap 221 between flangetop portion 226 and wings 220. In one embodiment, no protrusions such asprotrusions 116 and corresponding recesses 118 of applicator 100 may bepresent. N an alternative embodiment, protrusions such as 116 andcorresponding recesses like 118 may be present but they would bepositioned on the surface of conical portion 228. The protrusions wouldprovide a tactile or auditory cue to the user to indicate how far theyneeded to rotate the frangible member to activate the applicator andrelease the composition. Unlike the protrusions 116 and correspondingrecesses 118 shown in FIGS. 3 and 3A, the protrusions for the embodimentin FIGS. 5A, 5AA and 5B should have an angle of about 135° to about 175°on either side so as to allow the user to rotate over the protrusion andback again in order to activate the applicator. Rather, only flange topportion 226, including conical portion 228, capping weak point 210 maytwist relative to the remainder of body 202. FIG. 5A also illustrates analternative body 202 at the grippable handle portion, e.g., including acontainer body 202 that may be opaque, except for at viewing window orstripe 230. FIG. 5AA shows a close up of the distal end of applicator200, more clearly showing gap 221.

FIG. 5B shows another applicator 300, similar to applicator 100, butwith a differently configured frangible member 308 and surroundingdistal portions of container body 302. As in applicator 200, only thetop portion 326 of applicator may twist during breaking. For example,wings 320 may be attached to neck 314, and remain therewith as the topflange 326 is broken off with sealing cap 330 by twisting rotationrelative to enlarged stop 328 and the remainder of container body 302.Such action opens a fluid pathway from container body 302 through brokenweak point 310, and into an attached porous head. A gap 321 may bepresent between top portion 326 and wings 320, to facilitate breakage atweak point 310. Wings 320 are shown as including barbed lateralextensions 332, which may further aid in retaining the distal end ofcontainer body 302 within a corresponding recess 111 of a porous head112. In an alternative embodiment, the barbs may also be present on thetop portion 326 of the applicator.

IV. Methods of Manufacture

The applicator may be manufactured using a blow-fill-seal process, whichmay be particularly beneficial, as a single apparatus or machine may beused to form and fill the applicator, all in a single process. Such asingle process provides improved sterility as compared to a processrequiring multiple machines (e.g., one to form the container, another tofill the container, and possibly another to seal the container). Byforming the container, immediately filling the container, andimmediately sealing the container, such an integrated blow-fill-sealprocess provides a sealed container, all within a short period of time,with no waiting or storage of intermediate manufactures, while theprocess is completed. For example, such a process includes lessopportunity for contamination to occur as compared to forming thecontainers, after which the formed containers may be stored for alengthy period of time, followed by retrieving containers from storage,filling the containers, and then sealing the containers. The sealedcontainers formed by such an integrated blow-fill-seal process may besterilized, as needed (e.g., thermal sterilization, chemicalsterilization (ethylene oxide, ozone, etc.), sterilization by radiation(gamma, electron beam, UV, etc.) and other suitable sterilizationtechniques) and have the porous applicator head attached over the distalend of the filled container. Placement of the applicator head 112 mayoccur prior to or after any ethylene oxide or similar sterilizationstep.

Because of the improvement in sterility offered by an integratedblow-fill-seal process, the sterilizing process may not need to be asrigorous as would otherwise be required. For example, lower ethyleneoxide concentrations and/or exposure times may be suitable, while stillproviding a given level of sterilization. This may reduce ethylene oxidepenetration into the composition, through the container body 102, whichhas heretofore been a recurring problem. For example, as a result, asingle layer of polymeric material, with or without a barrier materialcompounded therein may be sufficient to meet the above describedethylene oxide penetration standards (e.g., less than 250 ppm, less than100 ppm, less than 25 ppm of residual ethylene oxide within thecomposition). Similarly, where lower ethylene oxide concentrationsand/or contact times may be suitable to achieve a given sterility level,the container body may be able to exhibit a permeability to gaseousethylene oxide of greater than 20 mg/hr/cm² and still be able to meetthe above described ppm levels of residual ethylene oxide in thecomposition. In an embodiment, at least 60% of the surface area of thecontainer body may consist of a single layer of material. In anembodiment, the entire surface area of the container body may consist ofa single layer of material.

FIG. 6 shows an exemplary method S100, including extruding a polymericmaterial at S110, placing the extruded material into a blow mold atS120, and at S130, molding the extruded material by placing a blow pininto the neck of the extruded material using pressure (e.g., providedthrough the blow pin) to form the material into a container body shape(e.g., container body 102). Pressure (e.g., from a compressed gas), orvacuum pressure may be used to mold the material into the desiredcontainer body shape. At S140, the container body is filled with theaseptic composition, which composition may comprise an alcohol, a dye orcolorant, and an antimicrobial agent (e.g., antiseptic agent, antiviralagent, etc.). The composition may be introduced into the container bodythrough the blow pin (e.g., the same blow pin used to form the polymericmaterial into a container body shape). Once the container body isfilled, at S150, the blow pin may be retracted, which retraction resultsin the formation of a frangible member (e.g., frangible member 108,specifically weak point 110), sealing the composition within the filledcontainer body. At S160, the porous applicator head (e.g., head 112) maybe attached to the unitary structure of the container body (i.e.,frangible member 108 and the remainder of body 102) to form the finishedapplicator. Steps S110 through S150 may be performed in sequence, all onthe same blow-fill-seal apparatus.

Once formed, at step S170, the applicator may be sterilized (e.g., usingethylene oxide gas). Other sterilization techniques, e.g., sterilizationby radiation (UV, gamma, electron beam, etc.), dry heat sterilization,steam sterilization, chemical sterilization (ethylene oxide, ozone,etc.) etc., may additionally or alternatively be employed.

Once sterilized, the applicator may be packaged into an externalpackaging material, e.g., comprising at least one flexible portion. FIG.7 illustrates a sterilized applicator 100 packaged within packagingmaterial 132, which material 132 includes at least one flexible portion.Such a package may be provided to the practitioner, and the practitionermay open the package, and use the applicator as described herein toapply the aseptic/antiseptic composition to the skin of a patient, e.g.,by twisting head 112 (and frangible member 108) relative to theremainder of body 102 (e.g., handle 103), breaking weak point 110, so asto allow flow of composition out body 102, through an opening at brokenweak point 110, and into head 112. By squeezing handle portion 103 ofbody 102, the practitioner may accelerate delivery of the compositionover the flow path from body 102, out the opening at 110, soaking head112, to the patient's skin. By providing at least a portion of body 102with translucency or transparency, the practitioner may easily andreadily visually ascertain how much composition remains to be dispensed.

Although described principally in the context of an applicator forapplying an antiseptic composition, it will be appreciated that similarapplicators (e.g., not necessarily including an applicator head) may beprovided in other fields, e.g., for application of topical drugs,personal care compositions such as lotions, make-up, self-tanner, etc.,paints, dyes, stains, glues, other adhesives, hard or soft surfacecleaners, food marinates or flavors, etc.

Without departing from the spirit and scope of this invention, one ofordinary skill can make various changes and modifications to theinvention to adapt it to various usages and conditions. As such, thesechanges and modifications are properly, equitably, and intended to be,within the full range of equivalence of the following claims.

The invention claimed is:
 1. A method of making an aseptic applicatorcomprising the steps of: (a) molding an extruded polymer material byplacing a blow pin into a first end of the extruded material and usingpressure to form the material into a container body shape comprising aneck portion having a plurality of outwardly extending protrusions atthe first end and a substantially hollow handle at a second end; (b)filling said container body at the first end, using said blow pin, withan aseptic composition comprising: (i) an antimicrobial agent and (ii)an alcohol; (c) retracting said blow pin, creating a frangible member atthe first end having one or more wings extending toward the second endand adjacent the outwardly extending protrusions of the neck portion ofthe container body, and sealing the filled container body at the firstend, the frangible member and filled container body being a sealedunitary structure of said polymeric material; (d) attaching a porousapplicator head to said unitary structure at the first end to form theaseptic applicator; and (e) retaining the porous applicator head withthe one or more wings which extend adjacent to the neck portion of thecontainer body.
 2. The method of claim 1, wherein said polymericmaterial is selected from the group consisting of: polyolefins,polypropylene, polyethylene, high density polyethylene, low densitypolyethylene, ethylene/propylene copolymers, ethylene/butylenecopolymers, vinyl, vinyl polymers, acrylic polymers, polyesters,polyethylene terephthalate, polybutylene terephthalate, polyvinylalcohol, polyamides, polyvinylchloride, polyvinylidene chloride,ethylene vinyl alcohol, chlorotrifluoroethylene,polytetrafluoroethylene, polyvinylidene fluoride, copolymers ofperfluorinated monomers with partially fluorinated monomers,tetrafluoroethylene/hexafluoropropylene/vinylidene, and any mixtures orcombinations thereof.
 3. The method of claim 2, wherein an inorganicoxide material is incorporated into the polymeric material from whichthe container body and frangible member are formed.
 4. The method ofclaim 1, wherein said polymeric material is translucent.
 5. The methodof claim 1, wherein said container body is flexible and deforms underpressure.
 6. The method of claim 1, wherein said antimicrobial agent isat least one of chlorhexidine gluconate or povidone iodine.
 7. Themethod of claim 1, wherein said alcohol is selected from the groupconsisting of: methanol, ethanol, isopropyl alcohol, and butyl alcohol,and any mixtures or combinations thereof.
 8. The method of claim 1,further comprising the step of: (h) sterilizing said aseptic applicatorusing ethylene oxide gas.
 9. The method of claim 8, wherein thecontainer body is formed from a single layer of the polymeric materialand less than 250 ppm of ethylene oxide penetrates the asepticapplicator into the aseptic composition during sterilization.
 10. Themethod of claim 8, wherein less than 100 ppm of ethylene oxidepenetrates the aseptic applicator into the aseptic composition duringsterilization.
 11. The method of claim 1, wherein vacuum pressure isused to mold the material into the container body shape.
 12. The methodof claim 1, wherein pressure from compressed gas is used to mold thematerial into the container body shape.
 13. The method of claim 1,further comprising the step of: (h) sterilizing said aseptic applicatorusing one or more of the following methods: ethylene oxide gassterilization, dry heat sterilization, UV sterilization, steamsterilization or any combinations thereof.
 14. A method of making anaseptic applicator comprising the steps of: (a) molding an extrudedpolymer material by placing a blow pin into a first end of the extrudedmaterial and using pressure from the blow pin to form the material intoan elongate container body shape having an axis extending between thefirst end and a second end; (b) filling said container body using saidblow pin with an aseptic composition comprising: (i) antimicrobialagent, (ii) an alcohol, and (iii) a dye or colorant; (c) retracting saidblow pin to form a frangible member at the first end, the step offorming the frangible member sealing the filled container body, thefrangible member and filled container body being a unitary structure;(d) attaching a porous applicator head to said unitary structure to formthe aseptic applicator; (e) retaining the porous applicator head withone or more wings extending from the frangible member, the wingscontaining one or more protrusions positioned adjacent to an undercutportion of said container, the undercut aligning with the one or more ofthe protrusions of the one or more wings to prevent substantial axialmovement after the frangible member is broken from the container body;and (0 sterilizing said aseptic applicator using ethylene oxide gas. 15.The method of claim 14, wherein the container body is formed from asingle layer of said polymeric material.
 16. The method of claim 14,wherein said antimicrobial agent is chlorhexidine gluconate.
 17. Themethod of claim 14, wherein less than 250 ppm of ethylene oxidepenetrates the aseptic applicator into the aseptic composition duringsterilization.
 18. The method of claim 14, wherein vacuum pressure isused to mold the material into the container body shape.
 19. The methodof claim 14, wherein pressure from compressed gas is used to mold thematerial into the container body shape.
 20. A method of making anaseptic applicator comprising the steps of: (a) molding an extrudedpolymer material by placing a blow pin into a first end of the extrudedmaterial and using pressure to form the material into a single layercontainer body shape comprising a neck portion at the first end, theneck having an undercut and a plurality of outwardly extendingprotrusions, and a substantially hollow handle at the second end; (b)filling said container body using said blow pin with an asepticcomposition comprising: (i) antimicrobial agent, (ii) an alcohol, and(iii) a dye or colorant; (c) retracting said blow pin to create afrangible member at the first end and sealing the frangible member toform a frangible member having one or more wings extending toward thesecond end and adjacent the neck of the container body, the wings of thefrangible member each comprising at least one inward protrusionextending between outwardly extending protrusions of the neck portion,the frangible member and filled container body being a unitarystructure; (d) attaching a porous applicator head to said unitarystructure wherein the one or more wings which extend adjacent to theneck portion of the container body and the outwardly extendingprotrusions of the neck portion retain the porous applicator head; (e)sterilizing said aseptic applicator using ethylene oxide gas; and (f)packaging said sterilized aseptic applicator into an external packagingcomprising at least one flexible portion.